Quality Assurance Document Control (QADC) Associate Specialist

SSi People
Bothell/ Washington
Full-time

Begin Your Career Adventure as a Quality Assurance Document Control (QADC) Associate Specialist!

Location : Bothell, WA (Onsite)

Shift : Sunday - Thursday, 10 : 00pm - 6 : 30am

Are you ready to make a meaningful impact in the world of cGMP Document Control operations? We're seeking a motivated individual to join our team at the Company’s Jump site as a Quality Assurance Document Control (QADC) Associate Specialist.

Key Responsibilities Include :

  • Issuing production batch records, labels, and controlled documents to support manufacturing operations.
  • Organizing and managing cGXP controlled document files within the Document Center and Archive room.
  • Managing the electronic document system for the JuMP site, including reviewing and approving document change requests.
  • Writing and revising document control procedures, as needed, to ensure compliance.
  • Supporting internal and external audits and regulatory inspections.
  • Performing Document Control metric reporting and analysis to drive continuous improvement.
  • Providing clear communication on the status of Quality Systems deliverables to customers, management, and stakeholders.

Top Skills We're Looking For :

  • Strong Communication : Engage with stakeholders effectively and provide excellent customer service.
  • Innovation : Bring fresh ideas and proactive problem-solving skills to the table.
  • Time Management : Prioritize tasks, manage time efficiently, and multitask effectively.
  • Technical Proficiency : Excel in using Smartsheet and Excel for document management tasks.
  • Attention to Detail : Demonstrate meticulous attention to detail when reviewing SOPs, procedures, and annotations within EDMS.
  • Technical Writing : Possess the ability to express Quality principles and critically review documents.
  • Regulatory Knowledge : Experience with FDA or other regulatory agencies and a solid understanding of cGMPs and domestic regulatory requirements.

Join us and be part of a team dedicated to excellence in quality assurance and document control. Apply now to embark on a rewarding career journey with us!

About SSi People :

With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team.

Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly.

More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.

30+ days ago
Related jobs
Promoted
VirtualVocations
Seattle, Washington

A company is looking for a Quality Assurance Associate. ...

Promoted
TSR Consulting Services, Inc.
Bothell, Washington

We are seeking a dedicated Quality Control Associate to join our team. The primary focus of the Quality Control Associate I role will be to support drug product lot release. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assis...

Boeing
Seattle, Washington

Entry-Level and Associate Quality Specialist. Quality Salaried professionals’ partner with and lead cross-functional business units to protect the integrity of products and processes, effectively ensuring that every product and service meets quality and regulatory requirements. Supports reviews of p...

Merck KGaA, Darmstadt, Germany
Bellevue, Washington

The Quality Assurance Specialist-Lot Release position at MilliporeSigma in Bellevue, Washington involves compliance to quality standards to meet specifications and good documentation practices. Timely communication of quality events and/or issues that have been detected during documentation/records ...

Davis Wright Tremaine LLP
Seattle, Washington

Excellent PC skills and significant experience supporting desktop applications such as Microsoft Office, NetDocuments (or other document management system), and other software specific to legal industry. Assure adherence to established QA standards and corresponding documentation. ...

Bristol Myers Squibb
Bothell, Washington

Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. Assist the QA department in maintaining the Quality focused cultur...

Innova Solutions
Bothell, Washington

As a Quality Assurance Specialist,. A minimum of 3 years of experience in pharmaceutical Quality Assurance, with direct experience in Quality Management Systems. Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data...

CRH
Seattle, Washington

The Quality Control Specialist must become familiar with the ISO 14001 requirements. Assists chief chemist with the daily quality control of plant operations. Works combined chemical/physical testing on weekends to provide quality assurance. Under general supervision and according to established pol...

Axelon Services Corporation
Bothell, Washington

The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and ...

Cynet Systems
Bothell, Washington

A minimum of 3 years of experience in pharmaceutical Quality Assurance, with direct experience in Quality Management Systems (Veeva experience preferred). Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data and me...